Gordon R. Bernard, MD, Melinda Owen Bass Professor of Medicine, Executive Vice President for Research, and Director, Vanderbilt Institute for Clinical and Translational Research at the Vanderbilt University Medical Center
Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience
Pragmatic clinical trials; CTSA; Clinical and Translational Science Award; Learning healthcare system; Translational science; Study design
- Vanderbilt’s CTSA program serves as a reusable platform to foster a learning healthcare system. The platform consists of study-specific tailoring for protocol customization and endpoint selection, as well as a reusable fixed infrastructure for institutional and regulatory policy, master protocols, clinical decision support, clinical registries, real-time EHR data capture, expert cores, and a standing data and safety monitoring board.
- In a learning healthcare system, clinical operations are integrated with clinical research to support research endeavors that answer real-world questions in clinical settings. Novel study structures permit informatics-enhanced interventions and data collection.
Are there data to demonstrate the “value” of combining learning (research) with operations?
How do you present the idea of having a partnership between research and clinical care to the hospital? How do you get buy-in?
Is there concern that you will stifle evolving technologies that would work if done after a year or two of learning how to do it?
Prioritize study questions by evaluating how quickly it will take to get an answer, how important the question is, or whether there will be clear benefit to patient outcomes.
For More Information
Read more about Vanderbilt’s CTSA program at https://victr.vanderbilt.edu/pub/vuctsa/index.html.
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